Senior Computer System Validation Specialist

Ladders; United States; Remoto; USD 105.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work flexibility

Mentorship opportunities

Professional development

Cross-functional collaboration

Exposure to GxP systems

Descrizione del lavoro

Ladders is seeking a Senior Computer System Validation Specialist to lead validation strategy for GxP computerized systems in a highly regulated healthcare environment. You will partner with IT, Quality, and Compliance to ensure audit-ready systems and robust lifecycle documentation.

Remote role for US-based candidates, with mentorship responsibilities and opportunities to drive process improvements across validation activities and SDLC governance.

Competenze

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field.
• 5+ years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems.
• Strong knowledge of GxP regulations, including 21 CFR Part 11 and EU Annex 11.
• Proficiency in risk-based validation practices and validation lifecycle deliverables.
• Excellent technical writing and communication skills.
• Experience leading validation strategies for various systems.
• Ability to mentor junior team members and provide technical guidance.

Mansioni

• Lead validation and assurance strategy for GxP systems throughout their lifecycle
• Author and review validation lifecycle deliverables ensuring compliance and readiness
• Provide IT Quality and Compliance oversight for computerized systems and SDLC activities
• Support system lifecycle activities including validation, change control, and periodic reviews
• Mentor and coach junior CSV/CSA team members and cross-functional project teams
• Identify compliance gaps and process improvement opportunities
• Facilitate cross-functional meetings related to validation strategy and audit readiness

Conoscenze

CSV/CSA expertise

GxP validation

Regulatory compliance

Technical writing

Leadership & mentoring

Formazione

Bachelor’s degree in Computer Science or related field

Descrizione del lavoro

For our client, we are seeking a Senior Computer System Validation Specialist to join the team of a leader in the Healthcare space.

This role will lead validation strategy and quality oversight for GxP computerized systems across the system lifecycle. You will partner closely with IT, Quality, Compliance, and project teams to ensure systems are compliant, audit-ready, and supported by strong validation practices.

The position focuses on risk-based validation, change control, periodic review, and the creation of clear lifecycle documentation. It also offers the opportunity to mentor junior team members and help improve processes in a highly regulated healthcare environment.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $105,000 – $130,000 annually

Responsibilities

• Lead validation and assurance strategy for GxP systems throughout their lifecycle
• Author and review validation lifecycle deliverables ensuring compliance and readiness
• Provide IT Quality and Compliance oversight for computerized systems and SDLC activities
• Support system lifecycle activities including validation, change control, and periodic reviews
• Mentor and coach junior CSV/CSA team members and cross-functional project teams
• Identify compliance gaps and process improvement opportunities
• Facilitate cross-functional meetings related to validation strategy and audit readiness

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field
• 5+ years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems
• Strong knowledge of GxP regulations, including 21 CFR Part 11 and EU Annex 11
• Proficiency in risk-based validation practices and validation lifecycle deliverables
• Excellent technical writing and communication skills
• Experience leading validation strategies for various systems
• Ability to mentor junior team members and provide technical guidance

Benefits

• Remote work flexibility with a preference for East Coast candidates
• Opportunity for professional development and mentorship
• Engagement in high-impact projects within a regulated environment
• Collaboration with cross-functional teams
• Exposure to a variety of GxP systems and validation practices

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.